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Developing Therapies for Traumatic Brain Injury

NCT01420939 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2019-12-12

No results posted yet for this study

Summary

Background:

\- A person who has a traumatic brain injury (TBI) -- also called concussion -- can have serious and long-lasting effects. Doctors who treat TBI need more information about how the brain changes over time in people with TBI and how well a person recovers from it. To make existing TBI treatments more effective and develop new ones, researchers want to look more closely at how TBI affects people both physically and psychologically.

Objectives:

\- To collect medical information from people with recent traumatic brain injury and compare this information to that of healthy volunteers and of persons who have had injuries to other parts of their bodies besides their heads (such as broken bones, orthopedic injuries, after surgery).

Eligibility:

3 groups of people between the ages of 18 and 70 years will be asked to take part.

* Persons who have had a traumatic brain injury (or concussion ) within the past 30 days, OR
* Persons who are healthy and have never had a traumatic brain injury, OR
* Persons who have had an injury within the past 30 days to a part of their body other than the head (such as a broken bone, orthopedic injury, surgery)

Design:

* This study requires two outpatient visits each lasting 1 1/2 days. The 2 visits will be about 30 days apart. Persons with TBI and non-TBI injuries must have their first visit within 30 days of their injury.
* Screening: Participants will be screened with a medical history, physical examination, blood tests and electrocradiogram (ECG a routine heart test).
* The research will involve:

1. Giving blood samples (no more than 75 ml each visit).
2. Having tests of memory, attention, concentration, and thinking (neuropsychological testing).
3. Having imaging studies of the head including magnetic resonance imaging (MRI) and positron emission tomography (PET) scans.
* Persons with TBI will have the same tests at Visit 1 and 2. Healthy controls and persons with non-TBI injuries will have the same tests at Visit 1 as listed above. But, at Visit 2, they will not have brain MRIs or PETs.
* No treatments will be provided as part of this research protocol.

Conditions

Sponsors & Collaborators

  • National Institute of Nursing Research (NINR)

    lead NIH

Principal Investigators

  • Jessica Gill, Ph.D. · National Institute of Nursing Research (NINR)

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-21
Completion
2013-05-21

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01420939 on ClinicalTrials.gov